Study of Optimal Clopidogrel Duration in Patients Receiving Drug Eluting Stents (SCORE Trial)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Subhash Banerjee, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT00781573
First received: October 28, 2008
Last updated: November 1, 2013
Last verified: November 2013

October 28, 2008
November 1, 2013
September 2008
March 2013   (final data collection date for primary outcome measure)
Death and Myocardial Infarction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00781573 on ClinicalTrials.gov Archive Site
Combined endpoints of death, myocardial infarction, repeat revascularization, stroke and major/minor bleeding [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study of Optimal Clopidogrel Duration in Patients Receiving Drug Eluting Stents (SCORE Trial)
Study of Optimal Clopidogrel Duration in Patients Receiving Drug Eluting Stents (SCORE Trial)

Although the optimal duration of clopidogrel (an anti-platelet agent) therapy has been established after bare metal stent implantation in the blood vessels of the heart, there is lack of consensus regarding the optimal duration of therapy after implantation of a drug eluting stents (DES). Current American College of Cardiology guidelines recommend clopidogrel use for at least one year in the absence of contraindications after DES implantation, while recognizing that the optimal duration remains unknown. While an extended clopidogrel therapy (that is beyond the current 1 year recommendation) may increase bleeding complication, it may reduce the rates of adverse cardiovascular events like heart attacks and repeat revascularization procedures. A clinical trial which randomizes patients with an uneventful one year course after a DES implantation, to an additional year of clopidogrel and aspirin therapy versus aspirin alone, will be able to answer the important question about the role of extended (2y) dual anti-platelet therapy with clopidogrel and aspirin after DES implants. The investigators hypothesize that clopidogrel discontinuation at 1 year post-DES implantation is associated with an increase in cardiovascular events during the one year of follow-up period.

SCORE is a multicenter, prospective randomized study of post-percutaneous coronary intervention (PCI) patients with an uneventful 1 year post-PCI course on dual anti-platelet therapy (DAPT) with clopidogrel and aspirin. Patient will be randomized to an additional 1 year of DAPT (treatment arm) vs. aspirin alone (control arm)to assess the following endpoints during the 1 year follow-up period:

  1. Death / Myocardial infarction (MI) (Primary end-point)
  2. Combined endpoints of death, myocardial infarction, repeat revascularization, stroke, and major/minor bleeding (Secondary end-point)

During the year of follow up, subjects will be contacted once every three months. This will enable us to track study endpoints in the study population. In addition the patients' medical records will be screened to investigate if any of the aforementioned endpoints have been reached.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Myocardial Infarction
Drug: Clopidogrel
Clopidogrel, 75 mg QD, for one year
Other Name: Clopidogrel
  • Experimental: 1
    Clopidogrel (75 mg/day) is continued for another year at the completion of the initial year of clopidogrel and aspirin administration post DES implantation
    Intervention: Drug: Clopidogrel
  • No Intervention: 2
    Clopidogrel (75 mg/day) is stopped at the completion of the initial year of clopidogrel and aspirin administration post DES implantation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
280
March 2014
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Post-PCI patients receiving at least 1 DES
  • Completed 9-15 months follow-up free of MI, repeat revascularization
  • Able to provide informed consent
  • Have continued dual anti-platelet therapy with aspirin and clopidogrel for 1 year post-PCI

Exclusion Criteria:

  • Patients allergic to aspirin
  • Patients with aspirin resistance
  • Patients with allergy to clopidogrel
  • Patients on concomitant warfarin therapy
  • History of bleeding diathesis, coagulopathy, and/or platelet count < 100,000 cubic mm
  • Patients with a life expectancy less than 1 year due to active cancers (except basal cell carcinoma)
  • Pregnancy
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Greece,   India
 
NCT00781573
Dallas VA IRB #08-048
Yes
Subhash Banerjee, North Texas Veterans Healthcare System
North Texas Veterans Healthcare System
Not Provided
Principal Investigator: Subhash Banerjee, MD VA North Texas Healthcare System, UT Southwestern Medical Center
Study Director: Emmanouil S Brilakis, MD, PhD VA North Texas Healthcare System, Dallas, TX
North Texas Veterans Healthcare System
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP